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It's time for health chiefs to engage with skeptical citizens if sustainability and transformation plans are to succeed.

As real-world data (RWD) in health care begin to cross over to the Big Data realms, a panel of health economists was gathered to establish how well the current US policy environment further the goals of RWD and, if not, what can be done to improve matters. This report summarizes these discussions spanning the current US landscape of RWD availability and usefulness, private versus public development of RWD assets, the current inherent bias in terms of access to RWD, and guiding principles in providing quality assessments of new RWD studies. Three main conclusions emerge: (1) a business case is often required to incentivize investments in RWD assets. However, access restrictions for public data assets have failed to generate a proper market for these data and hence may have led to an underinvestment of public RWDs; (2) Very weak empirical evidence exist on for-profit entities misusing public RWD data entities to further their own agendas, which is the basis for supporting access restrictions of public RWD data; and (3) perhaps developing standardized metrics that could flag misuse of RWDs in an efficient way could help quell some of the fear of sharing public RWD assets with for-profit entities. It is hoped that these discussions and conclusions would pave the way for more rigorous and timely debates on the greater availability and accessibility of RWD assets.

The topic of transparency in industry-sponsored clinical trials has gathered the attention of researchers in medicine. Patient-level data from recently completed clinical trials is now available for investigators to reanalyze or perform new analyses. In this Special Communication, the authors discuss their experience using this type of research and provide recommendations for success., (© Copyright 2016 by the American Board of Family Medicine.)

I sketch a libertarian argument for the right to test in the context of 'direct to consumer' (DTC) genetic testing. A libertarian right to genetic tests, as defined here, relies on the idea of a moral right to self-ownership. I show how a libertarian right to test can be inferred from this general libertarian premise, at least as a prima facie right, shifting the burden of justification on regulators. I distinguish this distinctively libertarian position from some arguments based on considerations of utility or autonomy, which are sometimes labelled 'libertarian' because they oppose a tight regulation of the direct to consumer genetic testing sector. If one takes the libertarian right to test as a starting point, the whole discussion concerning autonomy and personal utility may be sidestepped. Finally, I briefly consider some considerations that justify the regulation of the DTC genetic testing market, compatible with the recognition of a prima facie right to test., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Death certificates and autopsy reports contain personal identifying information and clinical information protected under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. These documents are used, for example, by the families of the deceased for settling estates, bereavement and closure, and genetic counseling of relatives. Insurance companies, public health and law enforcement officials, and the legal community also have legitimate claims to this information. Critical ethical questions have not yet been settled about whether and when this information should be public and under which circumstances making this kind of information public incurs benefits, harms, or both. Additional considerations include which organizations-the media, academic institutions, or government agencies, for example-are best suited to interpret these questions and respond to them., (© 2016 American Medical Association. All Rights Reserved.)

Nuclear events and problems in siting procedures of nuclear plants poses problems of timely information and the question of proper and trustful information. This paper is divided into three parts. In the first part, the right to information and the Aarhus convention are analysed. The basic rights of the public in the field of environmental matters are presented and discussed. Such rights are also examined through the case law of the European Court of Human Rights. The second part deals with the problem of possible conflicts between the right to information (and environmental information) and obligations from NPT. The third part proposes some solutions to provide a balance between the obligation of giving information and the obligation of protecting certain information under the NPT.

Objective: The objective of the study is to examine attitudes towards aspects of donation treatment based on a national Swedish sample of gamete donors and couples undergoing assisted reproductive techniques (ART)., Methods: The present study was part of the Swedish study on gamete donation, a prospective longitudinal cohort study including all fertility clinics performing gamete donation in Sweden. The sample comprised 164 oocyte donors, 89 sperm donors, 251 people treated with their own gametes (in vitro fertilisation (IVF)), 213 oocyte recipients and 487 sperm recipients. A study-specific questionnaire was used., Results: Attitudes vary widely between couples using their own gametes for IVF and those receiving or donating oocyte or sperm. The groups differed in their responses to most questions. Oocyte and sperm donors were more likely to agree with the statements "The donor should be informed if the donation results in a child" and "Offspring should receive some information about the donor during mature adolescence" than recipients of donated gametes and couples treated with their own gametes., Conclusion: Donor recipients, IVF couples and donors expressed different attitudes towards openness and information when it came to gamete donation, and those differences seemed to depend on their current reproductive situation.

The Equal Employment Opportunity Commission (EEOC or Commission) is issuing a final rule to amend the regulations implementing Title II of the Genetic Information Nondiscrimination Act of 2008 as they relate to employer-sponsored wellness programs. This rule addresses the extent to which an employer may offer an inducement to an employee for the employee's spouse to provide information about the spouse's manifestation of disease or disorder as part of a health risk assessment (HRA) administered in connection with an employer-sponsored wellness program. Several technical changes to the existing regulations are included. Published elsewhere in this issue of the Federal Register, the EEOC also issued a final rule to amend the regulations and interpretive guidance implementing Title I of the Americans with Disabilities Act (ADA) that addresses the extent to which employers may use incentives to encourage employees to participate in wellness programs that ask them to respond to disability-related inquiries and/or undergo medical examinations.

Background: Clinical trial (and other) data from the European Medicines Agency (EMA) offers the best available opportunity to address the extensive reporting bias in pharmaceutical trial literature. Data are requested via freedom of information requests, but 5 years on, little is known about how the system is working., Methods: Case series of 12 requests for regulatory data (clinical study reports and other regulatory data) relating to 29 different compounds. We logged start and end dates for correspondence with and data releases from the EMA, the need for additional correspondence and appeal of initial negative decisions, and inspected data releases for redaction. We measured: time from initial request to first substantive response from the EMA, to final decision from the EMA (in case of appeal), to initial receipt of documents, and to completion of request; number of data transmission batches generated; number of pages received for each request; average number of pages per batch over time (for releases in multiple batches); judgment as to whether the request was satisfied., Results: We found great variability in time to receive an initial decision from the EMA (1 to 13 weeks). Additional correspondence with the EMA was necessary in 10 of 12 requests. Four of 12 were initially refused but 3 of 4 were allowed on appeal after 3 to 33 additional weeks. One request was denied despite appeal. Time to final decision was 1 to 43 weeks. We received data for 11 of 12 requests in 98 batches. While two requests remain outstanding as at June 2015 the remaining nine requests took a median 43 weeks to completion (range: 17 to 186 weeks). Despite redaction in 10 of 11 releases (mainly of researcher and participant identifying information), 8 requested were wholly satisfied., Conclusions: The EMA is the only regulator in the world that is routinely releasing original clinical trial data, but release can take considerable time to occur and often only after a lengthy correspondence. Given its importance for research and significance for transparency we suggest ways in which the process could be made more efficient.

Providing information to surgery patients is a form of health-care governed by clearly defined therapeutic and medicolegal rules, and in particular in France by the Act of March 4, 2002 and the Code of Good Practice. The patient's right to information is implemented in a face-to-face consultation, which should be fully codified, and in a specific clinical examination, followed by information regarding the affected organ, pathology, treatment options, possible surgery, and the preconditions, risks and results associated with the procedure. Information should be personalized and as complete as possible, communicating the state of knowledge as validated by scientific societies and medical institutions. State of the art technology (dedicated website, on-line information suites, etc.) is indispensable but needs to be mastered and to adhere to the guidelines of the Council of the National Order of Medicine. Information traceability, the retraction period and proof of content of the information are essential. A signed document delivered in an informative atmosphere optimizes the exercise. Patient information is an ethical and medicolegal obligation, but above all is the expression and demonstration of the health-care potential of the practitioner and our contribution to reducing the information gap, reinforcing the cement holding our society together., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity., (Copyright © 2015 Elsevier Inc. All rights reserved.)

This paper gives an overview of the Norwegian legislation on Universal Design of information and communication technology (ICT) and how the Norwegian Authority for Universal Design of ICT works to enforce and achieve the goals behind the legislation. The Authority uses indicators to check websites for compliance with the regulations. This paper describes the rationale and intended use for the indicators and how they are used for both supervision and benchmarks as well as a way of gathering data to give an overview of the current state of Universal Design of websites in Norway.

This article addresses how open access to DNA, RNA and amino acid sequences might be reconciled with the benefit-sharing obligations under the United Nations’ Convention on Biological Diversity and its Nagoya Protocol, the Food and Agriculture Organization of the United Nations’ International Treaty on Plant Genetic Resources for Food and Agriculture, and the World Health Organization’s Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. Tracing the evolution of open access databases, the article posits models for reconciling open access and benefit sharing; the article concludes, however, that none of the proposed solutions – monitoring and tracing, the contract model, and the copyright and database right model – provides a perfect solution. Each model does, however, suggest that open access to these sequences might be at least partially reconciled with benefit sharing.

This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors’ innovation incentives and that access facilitates new drug development. These claims are characterized in terms of public-good and common-resource dilemmas. The analysis finds confidentiality protection of primary research data plays an ambiguous role. While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common-resource problem, in view of data as a source of scientific knowledge. It is argued that the claim by the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against pro-access policies. While much attention has been paid to the problem of appropriability of drug R&D investment, this analysis highlights another consequence resulting from the private provision of clinical trials, i.e., factual confidentiality and possession of data by drug sponsors. The associated social costs are qualified in terms of internalized knowledge externalities. Since, in a competitive environment, companies are unlikely to change the strategy of non-sharing of primary data, the resulting economic inefficiencies at the sector level call for regulatory intervention. To reconcile the competing policy objectives, it is proposed that the rules of access should be designed in such a way that third-party use of primary data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximized when the “cooperative choice” (i.e., when everyone shares data) becomes the “dominant strategy.” This can be achieved only when access is not subject to the authorization of the initial trial sponsors, and when primary data is aggregated, refined, and managed on the collective basis.

The Occupational Safety and Health Act of 1970 and the Workers Right to Know laws later in that decade were signature moments in the history of occupational safety and health. We have examined how and why industry leaders came to accept that it was the obligation of business to provide information about the dangers to health of the materials that workers encountered. Informing workers about the hazards of the job had plagued labor-management relations and fed labor disputes, strikes, and even pitched battles during the turn of the century decades. Industry's rhetorical embrace of the responsibility to inform was part of its argument that government regulation of the workplace was not necessary because private corporations were doing it.

This article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years. In the second, the entire regulatory framework on biobanking and genomic research is analyzed. The third part focuses on the critical evaluation of this regulatory framework, specifically on some major ethical dilemmas in biobanking. The fourth part describes the characteristics of the Brazilian biobanking and human research governance system, known as the CEP/CONEP system. Finally, the conclusion summarizes the information in the article and its contribution to the study of the biobanking ethical challenges, especially the protection of privacy. It is highlighted that biobanking regulatory harmonization among countries is necessary, since it increases scientific possibilities that can come from broader cooperation among biobanks and several research centers on the national and international levels., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

The availability of biological samples and data is critical for the establishment of biobanks for health research purposes. Such availability should be ensured in accordance with relevant national legislation and ethical principles. In this article, we consider the extent to which the current legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors. These two attributes are essential for establishing biobanks in the country. Our evaluation of the frameworks is based on desk review of the current literature with a special focus on oversight mechanisms in place that ensure compliance with national legislation and ethical review processes to facilitate future and secondary uses of data, the extent to which informed consent policies foster sharing of research samples, data and protocols as well as mechanisms for safeguarding confidentiality. We established that there is an urgent need to streamline South Africa's legal and ethical frameworks because they are currently ambiguous and disjointed. There is equally a need to bring the frameworks in line with the current developments at the national and international levels., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

Australian biobanks are largely autonomous and funded by local health care institutions, although some biobanks also receive funding from the National Health and Medical Research Council (NHMRC). There is no formal biobank legislation, but the NHMRC has developed biobanking guidelines. The regulation of biobanks is mainly through privacy laws and human research ethics committees. Australia is moving toward the use of broad consent for biobanking. International data sharing is permitted., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

Disease-based biobanks have operated in hospitals and research institutes in China for decades, and China has recently embarked on a plan to establish further biobank networks with the aim of promoting data sharing among the existing biobanks. Although the Chinese Constitution has only recently begun to recognize individual privacy as a distinct and independent constitutional right, biobanking in China has been loosely regulated under a patchwork of sometimes overlapping laws (such as the Interim Measures for the Administration of Human Genetic Resources) and regulatory instruments, as well as and the policies of individual biobanks and networks of biobanks (such as the Shanghai Biobank Network Guidelines). A Draft Ordinance on Human Genetics Resources is currently being developed that will deal in more detail than previous laws with issues such as management measures, legal liability, and punishment for violations. International data sharing will be tightly regulated under this new law, and individual biobanks' policies such as the Shanghai Guidelines may choose to regulate such sharing even more. In contrast with national regulatory instruments, the Shanghai Guidelines also contain detailed de-identification policies, and explicitly endorse broad consent., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

This paper introduces legal framework and governance structure in relation to the management and development of biobanks in Taiwan. At first, we briefly describe Taiwan's population, political system and health care system. Secondly, this research introduces biobanking framework of Taiwan including 25 biobanks established with the approval of the Ministry of Health and Welfare. In those biobanks, "Taiwan Biobank" is the first and the largest government-supported biobank which comprises population-based cohort study and disease- oriented study. Since the collection of information, data, and biological specimen of biobanks often involve highly sensitive personal information, in the legal framework of Taiwan, there is a specific regulation, "Human Biobank Management Act" (HBMA), which plays an important role in regulating biobanks in Taiwan. HBMA, the Personal Information Act and other regulations constitute a comprehensive legal and regulatory privacy framework of biobanks. Through the introduction and analysis of the current legal framework applicable to biobanks, we found that there are several challenges that need to be solved appropriately that involve duplicate review systems, the obstacles in the international collaboration, and data sharing between biobanks in Taiwan., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

This article reviews international privacy norms governing human genomic biobanks and databases, and how they address issues related to consent, secondary use, de- identification, access, security, and governance. A range of international instruments were identified, varying in substance - e.g., human rights, data protection, research ethics, biobanks, and genetics - and legal character. Some norms detail processes for broad consent, namely, that even where potential participants cannot consent to specific users and uses, they should be given clear information on access policies, procedures, and governance structures. Some also give guidance about the conditions under which secondary use of data and samples without consent is appropriate, e.g., where consent is impracticable. International norms exhibit a confusing range of terminology relating to de-identification. They also continue to rely heavily on consent and anonymity as the basis for privacy protection, though governance is becoming more prominent. It may not be fatal that such a plurality of norms apply to biobanking; what is essential is that governance be built on shared values, our common interest in the success of genomic research, and practical tools that incentivize responsible, global sharing., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

Patients' treatment records often contain information critical to risk assessment. We sought to determine whether psychiatrists treating outpatients agree about the standard of care (SOC) for requesting records from a patient's past clinicians. This web-based survey invited psychiatrists to review a hypothetical outpatient clinical vignette and to indicate whether they would request a release of information (ROI) from the patient for treatment records from past clinicians. Respondents also described the community SOC for similar scenarios and what they would do if a patient refused the ROI. Data were collected from June 15 through June 19, 2012. Most psychiatrists would try to obtain treatment records from any therapist, psychiatrist, or primary care physician seen by the patient within the past year. Some would require the patient's consent to ROI as a prerequisite to treatment. Few respondents felt that obtaining records from several years ago would be necessary in a typical, moderate-risk outpatient case. In an average outpatient scenario, the SOC would be to request treatment records from the past year. Psychiatrists rely heavily on clinical judgment when determining whether to obtain medical records from other providers., (© 2015 American Academy of Psychiatry and the Law.)

Nigeria's commitment to genomic research and biobanking is beyond dispute. Proof, if there is need for one, is that the country is one of only six nations (others are Canada, China, Japan, the United Kingdom, and the United States) involved in the International HapMap Project. The HapMap Project is an innovative enterprise aimed at developing a haplotype map of the human genome, a tool that is helpful to studying the genetic basis of disease as well as the genetic or hereditary factors that contribute to variation in response to environmental factors, in susceptibility to infection, and in the effectiveness of, and adverse responses to, drugs and vaccines. In addition, the country is home to H3Africa biobank (with 45, 358 human samples in storage), affiliated with the Institute of Human Virology of Nigeria (IHVN), and several others. Benefits accruing from genomic research and biobanking are enormous; so also is protection of research subjects. The protection envisaged centers primarily on, inter alia, securing informed consent, safeguarding privacy and maintaining confidentiality of health information - all of which are enshrined in ethicolegal regimes in Nigeria. But whether these frameworks are consistent with international best practices is not at all clear, hence the need for this paper., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

The privacy of biobank research participants in France is protected by a combination of bioethics laws, research laws, and data protection laws. Although the law has attempted to facilitate research by creating an opt-out regime for research with pre-existing samples, other aspects of the law hinder research. The requirement for multiple consents throughout the process of biobank sample collection and use, the lack of acceptance of a broad consent for biobanking, and genetic exceptionalism in the law all complicate biobank research. With IRB approval, opt-out consent may be used for genetic research using human tissue collected for other purposes, but express consent is still required for research with the associated genetic data. Among the important issues remaining to be addressed are harmonizing and simplifying the various informed consent processes., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

Large-scale biobanks represents an important scientific and medical as well as a commercial opportunity. However, realizing these and other prospects requires social, legal, and regulatory conducive climate, as well as a capable scientific community and adequate infrastructure. Israel has been grappling with the appropriate approach to establishing such a repository, and debates over the governance, structure, finance, and mode of operation shed a bright light on the underlying social norms, civic engagement and scientific clout in steering a governmental response to pressing medical needs. The article presents the backdrop of the Israeli scene, and explores the reasons and forces at work behind the current formulation of the Israeli National Biobank, MIDGAM., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

The Spanish legal framework for the processing of samples and data with biomedical research purposes has sought to encourage scientific research, protect the right to freedom of research, and guarantee the interests of donors. The pillars of this legal framework are firstly, the duty to inform the donor in order to ensure that he or she is aware of the importance and the consequences of the donation; secondly, the control by ethics committees (RECs and External Ethics Committees of biobanks); and third, the supplementary application of the general rules on data protection. There are three different possibilities for processing samples (project, collection, and biobanks) - each one reinforcing specific consent or requiring other added guarantees. This system, which is applied consistently in the entire national territory, is producing very satisfactory results. However, there are some issues that need further policies or legal development, as the specific conditions and procedures for the international transfer of samples and data with research purposes., (© 2015 American Society of Law, Medicine & Ethics, Inc.)

Access to the Internet is increasingly critical for health information retrieval, access to certain government benefits and services, connectivity to friends and family members, and an array of commercial and social services that directly affect health. Yet older adults, particularly those with disabilities, are at risk of being left behind in this growing age- and disability-based digital divide. The Americans with Disabilities Act (ADA) was designed to guarantee older adults and persons with disabilities equal access to employment, retail, and other places of public accommodation. Yet older Internet users sometimes face challenges when they try to access the Internet because of disabilities associated with age. Current legal interpretations of the ADA, however, do not consider the Internet to be an entity covered by law. In this article, we examine the current state of Internet accessibility protection in the United States through the lens of the ADA, sections 504 and 508 of the Rehabilitation Act, state laws and industry guidelines. We then compare U.S. rules to those of OECD (Organisation for Economic Co-Operation and Development) countries, notably in the European Union, Canada, Japan, Australia, and the Nordic countries. Our policy recommendations follow from our analyses of these laws and guidelines, and we conclude that the biggest challenge in bridging the age- and disability-based digital divide is the need to extend accessibility requirements to private, not just governmental, entities and organizations., (© The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)